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Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative

Prospective Observational Study on Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05750706
Acronym
SEIFEM
Enrollment
150
Registered
2023-03-02
Start date
2022-06-01
Completion date
2026-03-31
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Adult, Invasive Fungal Infections

Brief summary

The study aims to evaluate incidence of invasive antifungal infections among patients with acute lymphoblastic leukemia Ph negative during the first weeks of treatment

Interventions

OTHERobservation of invasive fungal infections

observation of invasive fungal infections during chemotherapy

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER
Asst Degli Spedali Civili Di Brescia
CollaboratorOTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
CollaboratorOTHER
Campus Bio-Medico University
CollaboratorOTHER
Azienda Sanitaria Universitaria Friuli Centrale
CollaboratorOTHER
San Gallicano Dermatological Institute IRCCS
CollaboratorOTHER
University of Rome Tor Vergata
CollaboratorOTHER
University of Modena and Reggio Emilia
CollaboratorOTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
CollaboratorOTHER
Vito Fazzi Hospital
CollaboratorUNKNOWN
Azienda Ospedaliera di Padova
CollaboratorOTHER
San Raffaele University Hospital, Italy
CollaboratorOTHER
Azienda Ospedaliera Universitaria Integrata Verona
CollaboratorOTHER
Azienda Ospedaliero-Universitaria di Parma
CollaboratorOTHER
Azienda Ospedaliera "Sant'Andrea"
CollaboratorOTHER
S.Eugenio Hospital
CollaboratorOTHER
San Giovanni Addolorata Hospital
CollaboratorOTHER
Casa Sollievo della Sofferenza-IRCCS, San Giovanni Rotondo
CollaboratorUNKNOWN
ASST Sette Laghi
CollaboratorOTHER
Ospedale San Bortolo di Vicenza
CollaboratorOTHER
Fondazione IRCCS Policlinico San Matteo di Pavia
CollaboratorOTHER
A.O.U. Città della Salute e della Scienza
CollaboratorOTHER
Istituto Oncologico Veneto IRCCS
CollaboratorOTHER
Azienda Ospedaliera San Gerardo di Monza
CollaboratorOTHER
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
CollaboratorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* diagnosis of acute lymphoblastic leukemia Ph negative * age more than 18 yo

Exclusion criteria

* diagnosis of acute lymphoblastic leukemia Ph positive * acute lymphoblastic leukemia relapsed/refractory * lymphoblastic lymphoma

Design outcomes

Primary

MeasureTime frameDescription
Incidence of invasive fungal infections18 monthsIncidence of invasive fungal infections during first week of chemotherapy

Secondary

MeasureTime frameDescription
Mortality rate30 monthsMortality rate among patients with invasive fungal infections

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORMarianna Criscuolo

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026